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NCT Number: NCT07011056

A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma

The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma.

.The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles.

.Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.

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Key information

Conditions

Recurrent and Refractory Diffuse Large B-cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years, no gender restrictions;
  • Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);
  • Participants must have measurable disease;
  • ECOG≤2;
  • Adequate organ function

Exclusion criteria

  • Pregnancy or breastfeeding;
  • Previous history of transplantation;
  • Double/Triple Hit B cell lymphoma;
  • Patient with known active infection, or reactivation of a latent infection;
  • Any serious diseases that investigator deems inappropriate to participate.

Treatment and study plan

Purinostat Mesylate for Injection

Drug

The subjects in the experimental group will receive treatment with Purinostat Mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous infusion on days 1, 4, 8, and 11. The administration cycle lasts for 21 days, and the total treatment cycle is 6 cycles.

After 6 cycles, the investigator will assess whether the subjects can continue to benefit, whether they can sustain the treatment with the investigational drug, and adjust the frequency of continuous administration based on the evaluation results of the efficacy over these 6 cycles.

Selinexor Tablets

Drug

The recommended dose of selinexor tablets is 60 mg per administration, taken orally on the 1st and 3rd day of each week (for example, Monday and Wednesday, or Tuesday and Thursday), with a 4-week course as one treatment cycle. Patients who achieve partial response (judged by the investigator as the best expected response for the subject) or have better efficacy can switch to maintenance treatment, with a maintenance dose of 60 mg taken orally once a week.

Primary outcomes

  1. The Overall Survival

    Time frame: week 96

    The Overall Survival

Secondary outcomes

  1. The PFS assessed by BICR AND Investigator according to Lugano 2014

    Time frame: week 96

    The PFS assessed by BICR AND Investigator according to Lugano 2014

  2. The ORR assessed by BICR and Investigator according to Lugano 2014

    Time frame: week 96

    The ORR assessed by BICR and Investigator according to Lugano 2014

Study contacts

Contact information is provided by the study sponsor or research team.

Liangkun Sun

CONTACT

[email protected]

86+15885742617

Sponsors and collaborators

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Industry

Registry information

Official study title

A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 8, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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